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Research studies into the negative health effects of probiotic use

Despite the considerable interest in recent decades about the potential benefits of modifying the gastrointestinal flora by using probiotic supplementation, the evidence for its effectiveness has been conflicting. Although initial findings seemed to support the idea that supplementing with beneficial microorganisms such as Lactobacillus for a variety of conditions could only improve health outcomes, the following studies demonstrate that in some clinical settings the administration of probiotics has not only proven ineffective, but harmful.

Acidosis, bloating and brain fog

Rao S, Rehman A, Yu S, Martinez de Andino, N. Brain fogginess, gas and bloating: a link between SIBO, probiotics and metabolic acidosis. Clinical and Translational Gastroenterology (2018) 9:162. DOI 10.1038/s41424-018-0030-7
This is an observational study of the associations between brain fog, Small Intestinal Bowel Overgrowth (SIBO) and the consumption of probiotics. SIBO incidence was more common in the group of patients with brain fog than the group without. Patients in the group with brain fog were also more likely to show symptoms of D-lactic acidosis and slow GI transit. Symptoms resolved after discontinuation of probiotics and a course of antibiotics.
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Weight gain

Million M, Angelakis E, Paul M, Armougom F, Leibovici L, Raoult D. Comparative meta-analysis of the effect of Lactobacillus species on weight gain in humans and animals. Microbial Pathology (2012) 53(2):100-8. doi: 10.1016/j.micpath.2012.05.007.
This review is a meta-analysis of clinical studies and experimental models on both humans and animals, assessing the effects of Lactobacillus-containing probiotics on weight. The use of Lactobacillus acidophilus resulted in significant weight gain in humans and in animals. Lactobacillus plantarum was associated with weight loss in animals and Lactobacillus gasseri was associated with weight loss in both obese humans and animals.
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More sensitive to allergies

Taylor A, Dunstan J, Prescott S. Probiotic supplementation for the first 6 months of life fails to reduce the risk of atopic dermatitis and increases the risk of allergen sensitization in high-risk children: A randomized controlled trial. Journal of Allergy and Clinical Immunology (2007) 119(1): 184-91. Doi: 10.1016/j.jaci.2006.08.036.
The objective of this study was to determine whether early probiotic supplementation prevents allergic disease in high-risk infants. Newborn babies of women with allergy received either Lactobacillus acidophilus or placebo daily for the first 6 months of life. Children were subsequently assessed for atopic dermatitis (AD) and other symptoms at 6 and 12 months and had allergen prick tests at 12 months of age. At 6 months of age, the presence of Lactobacillus was associated with increased risk of subsequent cow’s milk sensitisation (allergy) and at 12 months the rate of allergic sensitisation was significantly higher in the probiotic group.
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Increased mortality with acute pancreatitis

Besselink M, Santvoort H, Buskens E, et al. Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. The Lancet (2008) 371 (9613): 651-659.
298 patients with predicted severe acute pancreatitis were randomly assigned to receive a multispecies probiotic or a placebo for a 28-day period. Infectious complications occurred in 30% of patients in the probiotic group and 28% in the placebo group. 16% of patients in the probiotic group died, compared with 6% in the placebo group. In the probiotic group 9 patients developed bowel ischaemia (diminished blood flow), 8 of whom died, compared with none in the placebo group. The study concludes that in patients with predicted severe acute pancreatitis, probiotic prophylaxis (preventative treatment) should not be administered.
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Higher risk of endocarditis

Encarnacion C, Loranger A, Bharatkumar M, Almassi G. Bacterial Endocarditis Caused by Lactobacillus acidophilus Leading to Rupture of Sinus of Valsalva Aneurysm. Texas Heart Institute Journal (2016) 43(2):161-164.
Case study of a man whose bacterial endocarditis (infection of the heart lining) caused by Lactobacillus acidophilus led to an aneurysmal rupture of the aortic sinus of the heart. The patient subsequently underwent successful surgical repair. Although the presence of lactobacilli in the GI tract is usually associated with protection against pathogens, improved immune function and positive effects on the host’s nutrition and colonic health, lactobacilli have also been identified in clinical reports as causative factors in dental caries, infectious endocarditis, urinary tract infections and abscesses. Probiotic agents that serve as entry vehicles for Lactobacillus have therefore been identified as possible new risk factors in the development of such infections.
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Other issues

Kochan P, Chmielarczyk A, Szymaniak L, et al. Lactobacillus rhamnosus administration causes sepsis in a cardiosurgical patient—is the time right to revise probiotic safety guidelines? Clinical Microbiology and Infection (2011) 17(10): 1589-1592. https://doi.org/10.1111/j.1469-0691.2011.03614.x
A 24-year-old female patient developed sepsis resulting from preoperative administration of probiotics following an aortic valve replacement. Blood cultures revealed the causative agent to be the probiotic Lactobacillus rhamnosus. Although probiotic use in hospitals has increased greatly in the past few years, there is growing evidence that for some patients (e.g., patients with organ failure, those who are immunocompromised, or have a dysfunctional gut barrier) the use of probiotics can cause infections. The report stresses the importance of establishing generally recognised safety guidelines.
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Doern C, Nguyen S, Afolabi F, Burnham C. Probiotic-associated aspiration pneumonia due to Lactobacillus rhamnosus. Journal of Clinical Microbiology (2014), July. https://doi.org/10.1128/JCM.01065-14
A case report of an 11-month-old female with trisomy 21 (Down syndrome) presenting with vomiting and fever. Respiratory syncytial virus (RSV) bronchiolitis (a common respiratory virus in infants) was diagnosed with additional bacterial superinfection. After bacterial culture, an organism was isolated and identified as Lactobacillus rhamnosus which was confirmed to be identically related to a strain of the same bacterium which the patient had been taking for the 3 months prior to her illness. To the study authors’ knowledge this is the first reported case of Lactobacillus pneumonia related to supplementation with probiotics.
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Kothari D, Patel S, Kim S. Probiotic supplements might not be universally effective and safe: A review. Biomedicine and Pharmacotherapy (2019) 111: 537-547.
Although numerous studies have substantiated the health-restoring potential of a restricted group of microbial species, some individuals including neonatal infants and adults with clinical conditions such as malignancies, leaky gut, diabetes, and post-organ transplant convalescence are unlikely to reap the benefits of probiotics. Furthermore, in such settings some probiotic strains might take advantage of the weak immunity in these vulnerable groups and turn into opportunistic pathogens engendering life-threatening pneumonia, endocarditis, and sepsis. The authors of the study urge that widespread probiotic usage in some clinical settings should be treated with caution.
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Jacobi C, Schulz C, Malfertheiner P. Treating critically ill patients with probiotics: beneficial or dangerous? Gut Pathogens (2011) 3(2).
A review of the current evidence of the use of beneficial microorganisms or probiotics in the treatment of critically ill patients in intensive care settings.
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